Examination gloves -Type C (Nitrile gloves)

K212290 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · LZA · Oct 28, 2021 · General Hospital

Device Facts

• Record ID: K212290
• Device Name: Examination gloves -Type C (Nitrile gloves)
• Applicant: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Examination gloves-Type C (Nitrile gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, blue nitrile rubber examination glove; single-layer; powder-free. Worn on examiner's hands or fingers during medical examinations to provide a barrier against contamination. Used in clinical settings; operated by healthcare professionals or for over-the-counter use by adults. Provides physical barrier protection; reduces risk of cross-contamination between patient and examiner.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Nitrile rubber compound; blue color; single-use; non-sterile. Dimensions and physical properties conform to ASTM D6319-19. Biocompatibility testing per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity). Barrier integrity per ASTM D5151-19. Residual powder per ASTM D6124-06.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Intended for adult use in medical examinations.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Powder Free Nitrile Examination Glove (Aqua Green) (K200326)

Submission Summary (Full Text)

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October 28, 2021

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Evan Hu Marketing Manager Shanghai Mind-link Consulting Co., Ltd. 639 Jiaozhou Road Shanghai, Shanghai 200040 China

Re: K212290

Trade/Device Name: Examination gloves -Type C (Nitrile gloves) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 26, 2021 Received: July 30, 2021

Dear Evan Hu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

#### K212290

Device Name

Examination gloves-Type C (Nitrile gloves)

#### Indications for Use (Describe)

The Examination gloves-Type C (Nitrile gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5.

510(k) Summary – K212290

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## 1. Submitter

Manufacturer: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. Address: No. 316 National road, Xinju, Changshan Town, Jinxian County, Nanchang City, 331724 Jiangxi Province, China. Contact person: Jenny Huang, 86-17702094798, [e-mail] Submission correspondent: Evan Hu, 86-18616124827, [e-mail], 639 Jiaozhou Road, Shanghai, 200040, China

## 2. Device

Trading name: Examination gloves – Type C (Nitrile gloves) Common name: Nitrile patient examination glove Classification name: Polymer patient examination glove Classification: Class I Product code: LZA

## 3. Predicate device

Primary device: Powder Free Nitrile Examination Glove (Aqua Green) (K200326)

## 4. Device description

The proposed device is one kind of patient examination glove made from nitrile rubber compounds. The typical characters of these examination gloves are blue color, single-layer, powder-free, non-sterilized, single-use, variable size (see table 2.). These examination gloves can be worn on the examiner's hands or fingers during a medical examination. In addition, it is for over-the-counter use and also for adult use only. The product specifications are shown in Table 1.

| Size | S | M | L | XL |
|--------------------------|-------|-------|--------|-------|
| Length, mm | ≥220 | ≥230 | ≥230 | ≥230 |
| Width, mm | 80±10 | 90±10 | 100±10 | ≥110 |
| Thickness of Palm*, mm | 0.080 | 0.080 | 0.080 | 0.080 |
| Thickness of Finger*, mm | 0.150 | 0.150 | 0.150 | 0.150 |

Table 1. Gloves specifications

*The minimum thickness of palm and finger

#### 5. Indication for use

The Examination Gloves-Type C (Nitrile gloves) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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# 6. Technological Characteristic Comparison between proposed and predicate devices

| Characters | Proposed device (K212290) | Predicate device (K200326) | Comparison |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product code | LZA | LZA | Same |
| Intended<br>use/<br>Indications<br>for Use | The Examination Gloves-Type C<br>(Nitrile gloves) is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | A powder free patient examination<br>glove is a disposable device<br>intended for medical purposes that<br>is worn on the examiner's hand or<br>finger to prevent contamination<br>between patient and examiner.<br>The device is for over- the- counter<br>use. | Same |
| Prescription<br>or over-the-<br>counter use | Over-the-counter use | Over-the-counter use | Same |
| Material | Nitrile compound | Nitrile compound | Same |
| Color | Blue | Aqua green | Different |
| Sterility | Non-sterilized | Non-sterilized | Same |
| Single-use | Single-use | Single-use | Same |
| Dimensions | Size S, M, L, XL, meet ASTM<br>D6319-19 | Size S, M, L, XL, meet ASTM D6319-<br>10 | Same |
| Physical<br>properties | Before and after aging properties,<br>meet ASTM D6319-19 | Before and after aging properties,<br>meet ASTM D6319-10 | Same |
| Freedom<br>from<br>pinholes | Meets ASTM D5151-19, AQL 2.5 | Meets ASTM D5151-06, AQL 2.5 | Same |
| Residual<br>powder | Meets ASTM D6124-06,<br><2mg/glove | Meets ASTM D6124-06,<br><2mg/glove | Same |
| Biocompatibi<br>lity | Non-irritant, meet ISO 10993-10<br><br>Non-sensitizing, meet ISO 10993-<br>10<br><br>Non-cytotoxic, meet ISO 10993-11 | Non-irritant, meet ISO 10993-10<br><br>Non-sensitizing, meet ISO 10993-<br>10<br><br>Non-cytotoxic, meet ISO 10993-11 | Same |

Table 2. Characteristics comparison

# 7. Summary of Non-Clinical Testing

The non-clinical tests of this proposed device are tested in conformance with the following standards:

- (a) ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves

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- (b) ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
- (c) ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- (d) ASTM D412-16, Standards test method for Vulcanized Rubber and Thermoplastics Elastomer - Tension
- (e) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization
- (f) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- (g) ISO 28590:2017, Sampling Procedure for Inspection by Attributes
- (h) ASTM D7160-16, Standard Practice for Determination of Expiration Dating for Medical Gloves
- (i) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

The performance and biocompatibility testing results are shown in Table 3.

| Standard | Test Description | Acceptance criteria | Results |
|--------------------------------------|-----------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------|
| ASTM D5151-19 | Freedom from holes | No water leakage (0 pinhole) | 0 pinhole found |
| ASTM D6319-19 | Physical Dimension | Multi acceptance criteria refer to ASTM D6319 Clause 7.4- TABLE 2. | Meet requirements. Refer to Table 4 below. |
| ASTM D6319-19, physical requirements | Tensile strength | Multi acceptance criteria refer to ASTM D6319 Clause 7.5- TABLE 3. | Meet requirements. Refer to Table 5 below. |
| ASTM D6124-06 | Residual powder | ≤2.0 mg/glove | 0.10mg/glove (before aging)<br>0.12mg/glove (after aging) |
| ISO 10993-10:2010 | Skin sensitization and irritation | No irritation and skin sensitization | No irritation and skin sensitization |
| ISO 10993-11:2017 | Systemic toxicity | No acute systemic toxicity | No acute systemic toxicity |

Table 3. A summary of the performance/biocompatibility testing results.

Table 4. Gloves size testing before and after aging, according to ASTM D6319

| Size | S | M | L | XL |
|------------------------------------|-------|-------|-------|-------|
| Before aging | | | | |
| Length, mm | 240 | 241 | 246 | 250 |
| Width, mm | 86 | 95 | 104 | 114 |
| Minimum thickness of<br>Palm, mm | 0.086 | 0.087 | 0.087 | 0.087 |
| Minimum thickness of<br>Finger, mm | 0.150 | 0.150 | 0.150 | 0.150 |

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| After aging at 60 °C for 158 days | | | | |
|------------------------------------|-------|-------|-------|-------|
| Length, mm | 240 | 241 | 246 | 250 |
| Width, mm | 86 | 95 | 104 | 114 |
| Minimum thickness of<br>Palm, mm | 0.086 | 0.087 | 0.087 | 0.087 |
| Minimum thickness of<br>Finger, mm | 0.150 | 0.150 | 0.150 | 0.150 |

Table 5. Gloves physical properties, pinhole testing results, and residual powder, before and after aging.

| Size | S | M | L | XL |
|-----------------------------------|-----|-----|-----|-----|
| Before aging | | | | |
| Tensile strength (MPa) | 32 | 33 | 33 | 34 |
| Elongation at break (%) | 566 | 574 | 576 | 585 |
| After aging at 60 °C for 158 days | | | | |
| Tensile strength (MPa) | 32 | 33 | 32 | 34 |
| Elongation at break (%) | 545 | 556 | 561 | 564 |

Clinical testing data is not applicable in this case.

## 8. Conclusion

The conclusions drawn from the non-clinical testing results demonstrates that the proposed device, Examination gloves – Type C (Nitrile gloves), is as safe, as effective and performs as well as or better than the legally marketed predicate device that cleared under K200326.